DIN EN 14180:2003-10
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
Hardcopy , PDF
English
01-10-2003
07-03-2021
National foreword
National Annex NA (informative) - Bibliography
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Technical requirements
5 Process control
6 Performance requirements
7 Sound power and vibration
8 Packaging, marking and labelling
9 Information to be supplied by the
manufacturer
10 Service and local environment
Annex A (normative) - Test methods
Annex B (normative) - Sterilizer classification
and testing
Annex C (normative) - Test equipment
Annex D (normative) - Determination of formaldehyde
residuals in a filter indicator
Annex E (informative) - Formaldehyde residues on
medical devices
Annex F (informative) - Environmental aspects
Annex ZA (informative) - Relationship between this
European Standard and the Essential
Requirements of EU Directive 93/42/EEC
on medical devices
Bibliography
Defines requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only.
| DevelopmentNote |
Supersedes DIN 58948-12 E and DIN 58948-13 E. Together with DIN 58948-17, supersedes DIN 58948-15 E. (02/2004)
|
| DocumentType |
Standard
|
| Pages |
52
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| Supersedes |
| Standards | Relationship |
| NEN EN 14180 : 2014 | Identical |
| NBN EN 14180 : 2014 | Identical |
| I.S. EN 14180:2014 | Identical |
| EN 14180:2014 | Identical |
| BS EN 14180:2014 | Identical |
| NF EN 14180 : 2014 | Identical |
| NS EN 14180 : 2014 | Identical |
| BS EN 14180 : 2003 | Equivalent |
| I.S. EN 14180:2003 | Equivalent |
| EN 14180:2003+A1:2009 | Equivalent |